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Erschienen in: Pediatric Cardiology 1/2013

01.01.2013 | Original Article

Rationale and Design of an International Multicenter Registry of Patients With Repaired Tetralogy of Fallot to Define Risk Factors for Late Adverse Outcomes: The INDICATOR Cohort

verfasst von: Anne Marie Valente, Kimberlee Gauvreau, Gabriele Egidy Assenza, Sonya V. Babu-Narayan, Sarah P. Evans, Michael Gatzoulis, Maarten Groenink, Ryo Inuzuka, Philip J. Kilner, Zeliha Koyak, Michael J. Landzberg, Barbara Mulder, Andrew J. Powell, Rachel Wald, Tal Geva

Erschienen in: Pediatric Cardiology | Ausgabe 1/2013

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Abstract

Although early survival after tetralogy of Fallot (TOF) repair in the modern era is excellent, studies on late outcomes have shown increasing rates of mortality and morbidity. Despite multiple publications on factors associated with late complications, risk factors for major outcomes (death and sustained ventricular tachycardia [VT]) remain poorly defined. Consequently, the International Multicenter TOF Registry (INDICATOR) was established. This article describes the development, structure, and goals of this registry and characterizes the initial cohort derived from four large congenital heart centers in the United States, Canada, and Europe. A data coordinating center with a core cardiac magnetic resonance (CMR) laboratory and statistical core was established. Subjects with repaired TOF who had CMR imaging performed between 1997 and 2010 and ≥1 year follow-up were included. Clinical end points were death and sustained VT. Demographic, electrophysiologic, exercise, and outcome data were collected. A total of 873 subjects fulfilled inclusion criteria (median age at repair 2.9 years and at CMR imaging 22.8 years). Of these, 9 % had QRS duration >180 ms on electrocardiogram (ECG). On CMR imaging, 38 % had severe right-ventricular (RV) dilatation (≥160 mL/m2), and 6 % had severe RV dysfunction (ejection fraction < 35 %). Of the 551 subjects with exercise testing available, 28 % had severely decreased exercise capacity with <50 % predicted peak oxygen consumption. The INDICATOR cohort allows robust statistical analysis to evaluate major clinical outcomes in patients with repaired TOF. Continued follow-up and further expansion of the registry may provide new insights into innovative therapeutic strategies to improve late outcomes.
Literatur
1.
Zurück zum Zitat Alfakih K, Plein S, Thiele H, Jones T, Ridgway JP, Sivananthan MU (2003) Normal human left and right ventricular dimensions for MRI as assessed by turbo gradient echo and steady-state free precession imaging sequences. J Magn Reson Imaging 17(3):323–329PubMedCrossRef Alfakih K, Plein S, Thiele H, Jones T, Ridgway JP, Sivananthan MU (2003) Normal human left and right ventricular dimensions for MRI as assessed by turbo gradient echo and steady-state free precession imaging sequences. J Magn Reson Imaging 17(3):323–329PubMedCrossRef
2.
Zurück zum Zitat Babu-Narayan SV, Kilner PJ, Li W, Moon JC, Goktekin O, Davlouros PA et al (2006) Ventricular fibrosis suggested by cardiovascular magnetic resonance in adults with repaired tetralogy of Fallot and its relationship to adverse markers of clinical outcome. Circulation 113(3):405–413PubMedCrossRef Babu-Narayan SV, Kilner PJ, Li W, Moon JC, Goktekin O, Davlouros PA et al (2006) Ventricular fibrosis suggested by cardiovascular magnetic resonance in adults with repaired tetralogy of Fallot and its relationship to adverse markers of clinical outcome. Circulation 113(3):405–413PubMedCrossRef
3.
Zurück zum Zitat Bacha EA, Scheule AM, Zurakowski D, Erickson LC, Hung J, Lang P et al (2001) Long-term results after early primary repair of tetralogy of Fallot. J Thorac Cardiovasc Surg 122(1):154–161PubMedCrossRef Bacha EA, Scheule AM, Zurakowski D, Erickson LC, Hung J, Lang P et al (2001) Long-term results after early primary repair of tetralogy of Fallot. J Thorac Cardiovasc Surg 122(1):154–161PubMedCrossRef
4.
Zurück zum Zitat Garg R, Powell AJ, Sena L, Marshall AC, Geva T (2005) Effects of metallic implants on magnetic resonance imaging evaluation of Fontan palliation. Am J Cardiol 95(5):688–691PubMedCrossRef Garg R, Powell AJ, Sena L, Marshall AC, Geva T (2005) Effects of metallic implants on magnetic resonance imaging evaluation of Fontan palliation. Am J Cardiol 95(5):688–691PubMedCrossRef
5.
Zurück zum Zitat Gatzoulis MA, Till JA, Somerville J, Redington AN (1995) Mechanoelectrical interaction in tetralogy of Fallot. QRS prolongation relates to right ventricular size and predicts malignant ventricular arrhythmias and sudden death. Circulation 92(2):231–237PubMedCrossRef Gatzoulis MA, Till JA, Somerville J, Redington AN (1995) Mechanoelectrical interaction in tetralogy of Fallot. QRS prolongation relates to right ventricular size and predicts malignant ventricular arrhythmias and sudden death. Circulation 92(2):231–237PubMedCrossRef
6.
Zurück zum Zitat Gatzoulis MA, Balaji S, Webber SA, Siu SC, Hokanson JS, Poile C et al (2000) Risk factors for arrhythmia and sudden cardiac death late after repair of tetralogy of Fallot: a multicentre study. Lancet 356(9234):975–981PubMedCrossRef Gatzoulis MA, Balaji S, Webber SA, Siu SC, Hokanson JS, Poile C et al (2000) Risk factors for arrhythmia and sudden cardiac death late after repair of tetralogy of Fallot: a multicentre study. Lancet 356(9234):975–981PubMedCrossRef
7.
Zurück zum Zitat Geva T (2011) Repaired tetralogy of Fallot: the roles of cardiovascular magnetic resonance in evaluating pathophysiology and for pulmonary valve replacement decision support. J Cardiovasc Magn Reson 13:9PubMedCrossRef Geva T (2011) Repaired tetralogy of Fallot: the roles of cardiovascular magnetic resonance in evaluating pathophysiology and for pulmonary valve replacement decision support. J Cardiovasc Magn Reson 13:9PubMedCrossRef
8.
Zurück zum Zitat Geva T, Sandweiss BM, Gauvreau K, Lock JE, Powell AJ (2004) Factors associated with impaired clinical status in long-term survivors of tetralogy of Fallot repair evaluated by magnetic resonance imaging. J Am Coll Cardiol 43(6):1068–1074PubMedCrossRef Geva T, Sandweiss BM, Gauvreau K, Lock JE, Powell AJ (2004) Factors associated with impaired clinical status in long-term survivors of tetralogy of Fallot repair evaluated by magnetic resonance imaging. J Am Coll Cardiol 43(6):1068–1074PubMedCrossRef
9.
Zurück zum Zitat Ghai A, Silversides C, Harris L, Webb GD, Siu SC, Therrien J (2002) Left ventricular dysfunction is a risk factor for sudden cardiac death in adults late after repair of tetralogy of Fallot. J Am Coll Cardiol 40(9):1675–1680PubMedCrossRef Ghai A, Silversides C, Harris L, Webb GD, Siu SC, Therrien J (2002) Left ventricular dysfunction is a risk factor for sudden cardiac death in adults late after repair of tetralogy of Fallot. J Am Coll Cardiol 40(9):1675–1680PubMedCrossRef
10.
Zurück zum Zitat Harrison DA, Harris L, Siu SC, MacLoghlin CJ, Connelly MS, Webb GD et al (1997) Sustained ventricular tachycardia in adult patients late after repair of tetralogy of Fallot. J Am Coll Cardiol 30(5):1368–1373PubMedCrossRef Harrison DA, Harris L, Siu SC, MacLoghlin CJ, Connelly MS, Webb GD et al (1997) Sustained ventricular tachycardia in adult patients late after repair of tetralogy of Fallot. J Am Coll Cardiol 30(5):1368–1373PubMedCrossRef
11.
Zurück zum Zitat Khairy P, Landzberg MJ, Gatzoulis MA, Lucron H, Lambert J, Marcon F et al (2004) Value of programmed ventricular stimulation after tetralogy of Fallot repair: a multicenter study. Circulation 109(16):1994–2000PubMedCrossRef Khairy P, Landzberg MJ, Gatzoulis MA, Lucron H, Lambert J, Marcon F et al (2004) Value of programmed ventricular stimulation after tetralogy of Fallot repair: a multicenter study. Circulation 109(16):1994–2000PubMedCrossRef
12.
Zurück zum Zitat Khairy P, Harris L, Landzberg MJ, Viswanathan S, Barlow A, Gatzoulis MA et al (2008) Implantable cardioverter-defibrillators in tetralogy of Fallot. Circulation 117(3):363–370PubMedCrossRef Khairy P, Harris L, Landzberg MJ, Viswanathan S, Barlow A, Gatzoulis MA et al (2008) Implantable cardioverter-defibrillators in tetralogy of Fallot. Circulation 117(3):363–370PubMedCrossRef
13.
Zurück zum Zitat Khairy P, Aboulhosn J, Gurvitz MZ, Opotowsky AR, Mongeon FP, Kay J et al (2010) Arrhythmia burden in adults with surgically repaired tetralogy of Fallot: a multi-institutional study. Circulation 122(9):868–875PubMedCrossRef Khairy P, Aboulhosn J, Gurvitz MZ, Opotowsky AR, Mongeon FP, Kay J et al (2010) Arrhythmia burden in adults with surgically repaired tetralogy of Fallot: a multi-institutional study. Circulation 122(9):868–875PubMedCrossRef
14.
Zurück zum Zitat Kilner PJ, Geva T, Kaemmerer H, Trindade PT, Schwitter J, Webb GD (2010) Recommendations for cardiovascular magnetic resonance in adults with congenital heart disease from the respective working groups of the European Society of Cardiology. Eur Heart J 31(7):794–805PubMedCrossRef Kilner PJ, Geva T, Kaemmerer H, Trindade PT, Schwitter J, Webb GD (2010) Recommendations for cardiovascular magnetic resonance in adults with congenital heart disease from the respective working groups of the European Society of Cardiology. Eur Heart J 31(7):794–805PubMedCrossRef
15.
Zurück zum Zitat Knauth AL, Gauvreau K, Powell AJ, Landzberg MJ, Walsh EP, Lock JE et al (2008) Ventricular size and function assessed by cardiac MRI predict major adverse clinical outcomes late after tetralogy of Fallot repair. Heart 94(2):211–216PubMedCrossRef Knauth AL, Gauvreau K, Powell AJ, Landzberg MJ, Walsh EP, Lock JE et al (2008) Ventricular size and function assessed by cardiac MRI predict major adverse clinical outcomes late after tetralogy of Fallot repair. Heart 94(2):211–216PubMedCrossRef
16.
Zurück zum Zitat Lu JC, Cotts TB, Agarwal PP, Attili AK, Dorfman AL (2010) Relation of right ventricular dilation, age of repair, and restrictive right ventricular physiology with patient-reported quality of life in adolescents and adults with repaired tetralogy of Fallot. Am J Cardiol 106(12):1798–1802PubMedCrossRef Lu JC, Cotts TB, Agarwal PP, Attili AK, Dorfman AL (2010) Relation of right ventricular dilation, age of repair, and restrictive right ventricular physiology with patient-reported quality of life in adolescents and adults with repaired tetralogy of Fallot. Am J Cardiol 106(12):1798–1802PubMedCrossRef
17.
Zurück zum Zitat Murphy JG, Gersh BJ, Mair DD, Fuster V, McGoon MD, Ilstrup DM et al (1993) Long-term outcome in patients undergoing surgical repair of tetralogy of Fallot. N Engl J Med 329(9):593–599PubMedCrossRef Murphy JG, Gersh BJ, Mair DD, Fuster V, McGoon MD, Ilstrup DM et al (1993) Long-term outcome in patients undergoing surgical repair of tetralogy of Fallot. N Engl J Med 329(9):593–599PubMedCrossRef
18.
Zurück zum Zitat Nollert G, Fischlein T, Bouterwek S, Bohmer C, Dewald O, Kreuzer E et al (1997) Long-term results of total repair of tetralogy of Fallot in adulthood: 35 years follow-up in 104 patients corrected at the age of 18 or older. Thorac Cardiovasc Surg 45(4):178–181PubMedCrossRef Nollert G, Fischlein T, Bouterwek S, Bohmer C, Dewald O, Kreuzer E et al (1997) Long-term results of total repair of tetralogy of Fallot in adulthood: 35 years follow-up in 104 patients corrected at the age of 18 or older. Thorac Cardiovasc Surg 45(4):178–181PubMedCrossRef
19.
Zurück zum Zitat Ortega M, Triedman JK, Geva T, Harrild DM (2011) Relation of left ventricular dyssynchrony measured by cardiac magnetic resonance tissue tracking in repaired tetralogy of Fallot to ventricular tachycardia and death. Am J Cardiol 107(10):1535–1540PubMedCrossRef Ortega M, Triedman JK, Geva T, Harrild DM (2011) Relation of left ventricular dyssynchrony measured by cardiac magnetic resonance tissue tracking in repaired tetralogy of Fallot to ventricular tachycardia and death. Am J Cardiol 107(10):1535–1540PubMedCrossRef
20.
Zurück zum Zitat Samyn MM, Powell AJ, Garg R, Sena L, Geva T (2007) Range of ventricular dimensions and function by steady-state free precession cine MRI in repaired tetralogy of Fallot: right ventricular outflow tract patch vs. conduit repair. J Magn Reson Imaging 26(4):934–940PubMedCrossRef Samyn MM, Powell AJ, Garg R, Sena L, Geva T (2007) Range of ventricular dimensions and function by steady-state free precession cine MRI in repaired tetralogy of Fallot: right ventricular outflow tract patch vs. conduit repair. J Magn Reson Imaging 26(4):934–940PubMedCrossRef
21.
Zurück zum Zitat Wald RM, Haber I, Wald R, Valente AM, Powell AJ, Geva T (2009) Effects of regional dysfunction and late gadolinium enhancement on global right ventricular function and exercise capacity in patients with repaired tetralogy of Fallot. Circulation 119(10):1370–1377PubMedCrossRef Wald RM, Haber I, Wald R, Valente AM, Powell AJ, Geva T (2009) Effects of regional dysfunction and late gadolinium enhancement on global right ventricular function and exercise capacity in patients with repaired tetralogy of Fallot. Circulation 119(10):1370–1377PubMedCrossRef
Metadaten
Titel
Rationale and Design of an International Multicenter Registry of Patients With Repaired Tetralogy of Fallot to Define Risk Factors for Late Adverse Outcomes: The INDICATOR Cohort
verfasst von
Anne Marie Valente
Kimberlee Gauvreau
Gabriele Egidy Assenza
Sonya V. Babu-Narayan
Sarah P. Evans
Michael Gatzoulis
Maarten Groenink
Ryo Inuzuka
Philip J. Kilner
Zeliha Koyak
Michael J. Landzberg
Barbara Mulder
Andrew J. Powell
Rachel Wald
Tal Geva
Publikationsdatum
01.01.2013
Verlag
Springer-Verlag
Erschienen in
Pediatric Cardiology / Ausgabe 1/2013
Print ISSN: 0172-0643
Elektronische ISSN: 1432-1971
DOI
https://doi.org/10.1007/s00246-012-0394-5

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